MULTICHEM ALKALINE PHOSPHATASE (S0903)

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

SIMMLER, INC.

The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Alkaline Phosphatase (s0903).

Pre-market Notification Details

Device IDK873761
510k NumberK873761
Device Name:MULTICHEM ALKALINE PHOSPHATASE (S0903)
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant SIMMLER, INC. POST OFFICE BOX 25179 St. Louis,  MO  63125
ContactQuincy E Crider,phd
CorrespondentQuincy E Crider,phd
SIMMLER, INC. POST OFFICE BOX 25179 St. Louis,  MO  63125
Product CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-16
Decision Date1987-10-07

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